ASTM F2027-2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products《组织工程医疗产品原料或初始材料的表征和试验的标准指南》.pdf

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1、Designation: F2027 08F2027 16Standard Guide forCharacterization and Testing of Raw or StartingBiomaterialsMaterials for Tissue-Engineered MedicalProducts1This standard is issued under the fixed designation F2027; the number immediately following the designation indicates the year oforiginal adoption

2、 or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This document provides guidance on writing a materials specification for raw

3、 or starting biomaterialsmaterials intended foruse in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply tobiomaterialsmaterials that are already in a scaffold form or are finished tissue-engineered medical products.1.2 The purpose o

4、f this guide is to provide a compendium of relevant existing standards and test methods for biomaterials-materials already commonly used within medical products and to provide characterization guidance for interim use of rawbiomaterialsmaterials for which a standard does not exist.1.3 This guide cov

5、ers specifications and characterizations of all the major classes of materials including polymers, ceramics,metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals.1.4 This guide is focused on specification of chemical, physical, and me

6、chanical properties of the raw or starting material. Itdoes not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materialsfabricated into a final form to include all possible effects of fabrication and sterilization techniques.1.5 Compli

7、ance with materials specifications developed in accordance with this standard may not necessarily result in a materialsuitable for its intended purpose. Additional testing specific to the intendintended use may be required.2. Referenced Documents2.1 ASTM Standards:2D1763 Specification for Epoxy Resi

8、nsD1898 Practice for Sampling of Plastics (Withdrawn 1998)3E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)3F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)F75

9、 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNSR30075)F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNSR30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI

10、(Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip

11、for Surgical Implants(UNS S31673)F451 Specification for Acrylic Bone Cement1 This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42on Biomaterials and Biomolecules for TEMPs.Current edition appr

12、oved May 1, 2008Oct. 1, 2016. Published June 2008December 2016. Originally approved in 2000. Last previous edition approved in 20002008 asF2027 00F2027 08.1. DOI: 10.1520/F2027-08.10.1520/F2027-16.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at

13、 serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standardsstandards Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.This document is not an ASTM standard and is intended only to provide

14、 the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the sta

15、ndard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F560 Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)F562 Specificatio

16、n for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications(UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical ImplantApplications (UNS R30563) (Withdrawn 2005)3F602 Criteria for Implantable Ther

17、moset Epoxy PlasticsF603 Specification for High-Purity Dense Aluminum Oxide for Medical ApplicationF604 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)3F619 Practice for Extraction of Medical PlasticsF624 Guide for Evaluation of Thermoplastic Polyurethane Solids a

18、nd Solutions for Biomedical ApplicationsF639 Specification for Polyethylene Plastics for Medical ApplicationsF641 Specification for Implantable Epoxy Electronic EncapsulantsF648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsF665 Classifica

19、tion for Vinyl Chloride Plastics Used in Biomedical ApplicationF702 Specification for Polysulfone Resin for Medical ApplicationsF755 Specification for Selection of Porous Polyethylene for Use in Surgical ImplantsF755 Specification for Selection of Porous Polyethylene for Use in Surgical ImplantsF997

20、 Specification for Polycarbonate Resin for Medical ApplicationsF1088 Specification for Beta-Tricalcium Phosphate for Surgical ImplantationF1185 Specification for Composition of Hydroxylapatite for Surgical ImplantsF1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (

21、Withdrawn 2012)3F1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum A

22、lloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)F1538 Specification for Glass and Glass Ceramic Biomaterials for ImplantationF1579 Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)3F1581 Specification for Composition of Anorga

23、nic Bone for Surgical ImplantsF1634 Practice forIn-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant DevicesF1635 Test Method forin vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms forSurgical ImplantsF1713 Specification for

24、Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)F1855 Specification for Polyoxymethylene (Acetal) for Medical ApplicationsF1873 Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical ImplantApplications (Withd

25、rawn 2007)3F1876 Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications (Withdrawn2012)3F1877 Practice for Characterization of ParticlesF1925 Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical ImplantsF1926F2026 Te

26、st Method for Evaluation of the Environmental Stability of Calcium Phosphate CoatingsSpecification forPolyetheretherketone (PEEK) Polymers for Surgical Implant ApplicationsF2064 Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and TissueEnginee

27、red Medical Product ApplicationsF2103 Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical andTissue-Engineered Medical Product ApplicationsF2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical

28、 ProductsF2212 Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for TissueEngineered Medical Products (TEMPs)F2259 Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear MagneticResonance (1H NMR) Spectro

29、scopyF2260 Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) SpectroscopyF2313 Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions GreaterThan or Equal to 70 % GlycolideF234

30、7 Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and TissueEngineered Medical Product ApplicationsF2579 Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical ImplantsF2848 Specification for Medical-Grad

31、e Ultra-High Molecular Weight Polyethylene YarnsF2027 162F3160 Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants2.2 Other Document:U.S. Pharmacopeia, Edition XXX or current edition4ISBT 128 The Global Information Standard for Medical Products of Human Ori

32、gin52.3 ISO and CEN Standards:6ISO 6474 Implants for SurgeryCeramic Materials Based on AluminaISO/IEC 17025 General Requirements for the Competence of Testing and Calibration LaboratoriesISO 10993-1 Biological Evaluation of Medical DevicesPart 1: Evaluation and TestingISO 10993-9Part 9: Framework fo

33、r Identification and Quantification of Potential Degradation ProductsISO 10993-12Part 12: Sample Preparation and Reference MaterialsISO 111607 Product PackagingISOISO/DIS 10993-13Part 13: Identification and Quantification of Potential Degradation Products from Polymeric MedicalDevicesISOISO/DIS 1099

34、3-14Part 14: Identification and Quantification of Potential Degradation Products from CeramicsISOISO/DIS 10993-15Part 15: Identification and Quantification of Potential Degradation Products from Metals and AlloysISOISO/DIS 10993-17Part 17: Methods for the Establishment of Allowable Limits for Leacha

35、ble Substances usingHealth-Based Risk AssessmentISO/CD 10993-18Part 18: Chemical Characterization of MaterialsISO/NWI 10993-19Part 19: Physico-chemical, Mechanical and Morphological Characterization of MaterialsBSI BS EN 12442-122442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture

36、 of Medical DevicesPart 1:Analysis and Management of RiskBSI BS EN 12442-2Part 2:22442-2 Animal Tissures and Their Derivative Utilized in the Manufacture of MedicalDevicesPart 2: Controls on Sourcing, Collection and HandlingBSI BS EN 12442-3Part 3:22442-3 Animal Tissures and Their Derivative Utilize

37、d in the Manufacture of MedicalDevicesPart 3: Validation of the Elimination and/or Inactivation of Virus and Transmissible AgentsISO 111607 Product Packaging2.4 Food and Drug Administration Documents:6,721 CFR Part Code of Federal Regulations, Title 21, Parts 610 General Biological Products Standard

38、s(General BiologicalProducts Standards), 820 (Quality system regulation), 1270 and 1271 (Human cells or tissue intended for implantation,transplantation, infusion, or transfer into a human recipient) or other of Parts 1-149921 CFR Part 820 Quality System Regulation721 CFR Part 1270Additional FDA Gui

39、dance Documents Human Tissue Intended for Transplantation821 CFR Part 1271Selected Guidance Documents Applicable to Combination Products Human Cells, Tissues, and Cellular andTissue Based Products93. Summary of Guide3.1 Novel materials that do not yet have standards associated with them are being cr

40、eated for use in tissue engineeringtissue-engineering applications. The lack of standardized specifications for the physical and chemical properties of these newmaterials may lead to variation between lots, which could create variation in observed biological performance of the final product.It is th

41、e intent of this guide to provide a compendium of existing medical product materials specifications and test methods to serveas a guide for specifying the important chemical and physical properties of new raw or starting materials. Tables of commonlyspecified chemical, physical, and mechanical requi

42、rements are provided for each type of material (for example, ceramic, metal,polymer, composite, natural product) to assist with the development of a specification for a new biomaterialmaterial to be utilizedfor tissue engineering.3.2 This guide is focused on providing a characterization template for

43、 raw or starting materials prior to their fabrication intoa scaffold or tissue-engineered medical product. Guidance for the characterization and testing of biomaterialsmaterials after theyhave been formulated into three-dimensional scaffolds can be found in Guide F2150.4 Available from U.S. Pharmaco

44、peia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http:/www.usp.org.5 Available from ICCBBA, P.O. Box 1309, San Bernadino, CA 92423-1309, http:/iccba.org.6 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.7 Avai

45、lable from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http:/www.fda.gov. Additional titles (Parts 11499) can be found atthrough this searchable database: http:/www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.8 FDA guidance documents searchable through t

46、his website, (http:/www.fda.gov/opacom/morechoices/industry/guidedc.htm). Selected Guidance Documents Applicableto Combination Products may be found at this website, (http:/www.fda.gov/oc/combination/guidance.html). Searchable through this website: http:/www.fda.gov/opacom/morechoices/industry/guide

47、dc.htm.9 Available at this wesite http:/www.fda.gov/oc/combination/guidance.html.F2027 1634. Significance and Use4.1 The physico-chemical characteristics of the raw or starting biomaterialmaterial used in regenerative medicine scaffoldscarries significant potential to affect product performance by i

48、nfluencing cell behavior and/or the release of bioactive moleculesor drugs. This guide describes recommended specifications or characterizations of raw or starting biomaterialsmaterials to ensurereproducibility prior to their fabrication into implantable tissue engineering tissue-engineering scaffol

49、ds and/or controlled releasematrices.5. Classification of BiomaterialsMaterials5.1 The properties of a biomaterial are a function of whichtissue-engineering scaffolds or cell delivery vehicles are, in part, afunction of the type of material from which they are made from. made. All materials can be classified according to their atomiccontent and bonding as either a ceramic, polymer, metal, or composite. Ceramics consist of ionically or covalently bonded metallicand non-metallic elements such as calcium phosphate or aluminum phosphate and include miner